The following data is part of a premarket notification filed by Xre Corp. with the FDA for Unicath Llu Angiographic System.
| Device ID | K945449 |
| 510k Number | K945449 |
| Device Name: | UNICATH LLU ANGIOGRAPHIC SYSTEM |
| Classification | System, X-ray, Angiographic |
| Applicant | XRE CORP. 300 FOSTER ST. PO BOX 1154 Littleton, MA 01460 -0754 |
| Contact | Wayne V Loomer |
| Correspondent | Wayne V Loomer XRE CORP. 300 FOSTER ST. PO BOX 1154 Littleton, MA 01460 -0754 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-07 |
| Decision Date | 1995-02-27 |